Chlorhexidine Mouthrinse Before EBUS-TBNA

Seoul National University Hospital112 enrolled

Overview

The purpose of this study is to investigate whether chlorhexidine mouthrinse is effective in preventing microbial contamination during endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA).

EBUS-TBNA using the convex probe is a standard of care for the assessment of mediastinal and hilar lymphadenopathy. Although EBUS-TBNA is a minimally invasive procedure, rare but serious infectious complications such as pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis were reported. EBUS-scope might be contaminated with oropharyngeal commensal bacteria while passing the oropharyngeal airway during EBUS-TBNA. Contamination of punctured lymph nodes by oropharyngeal commensal bacteria can cause severe infections. Chlorhexidine gluconate is an antimicrobial agent that has a broad antibacterial activity including both gram-positive and negative bacteria. Chlorhexidine has been widely used for surgical scrub, skin disinfection, and mouthrinse. We, therefore, designed a phase 4, single-center, randomized, controlled clinical trial to investigate whether chlorhexidine mouthrinse is effective in preventing microbial contamination during EBUS-TBNA.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

112

Conditions

Endobronchial Ultrasound

Interventions

Chlorhexidine Gluconate 0.12 % MouthwashDRUG

Intervention with chlorhexidine mouthrinse will be performed approximately 10 min before the start of EBUS-TBNA

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

Inclusion Criteria: * inpatients aged 19 years and older who are scheduled to undergo EBUS-TBNA using a convex probe Exclusion Criteria: * antiseptic mouthrinse within 7 days before inclusion; * active infection or antibiotic treatment within 7 days before inclusion; * immunocompromised; * trachemostomy status; * who have already undergone gastroscopy on the same day when EBUS- TBNA is scheduled to be administered

Locations (1)

Seoul National University Hospital

Seoul, South Korea

Outcomes

Primary Outcomes

Colony forming unit (CFU) counts of EBUS-TBNA needle wash solution in aerobic media

Needle wash solution is obtained by instilling 5mL of sterile physiological saline into the puncture needle.

Time frame: Needle wash solution is obtained immediately after termination of EBUS-TBNA

Secondary Outcomes

CFU counts of EBUS-TBNA needle wash solution in anaerobic media

Needle wash solution is obtained by instilling 5mL of sterile physiological saline into the puncture needle.

Time frame: Needle wash solution is obtained immediately after termination of EBUS-TBNA

Fever

Fever is defined as a temperature ≥37.8°C.

Time frame: 24 hours after EBUS-TBNA

Infectious complications

Infectious complications include pneumonia, lung abscess, empyema, mediastinal adenitis/abscess, mediastinitis, pericarditis, and sepsis.

Time frame: 4 weeks after EBUS-TBNA

Data from ClinicalTrials.gov

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